Sr Quality & Compliance Operations Specialist

Biopharma Asia; Antwerpen; On-site; EUR 74,000 - 118,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Well-being reimbursement

Job summary

Johnson & Johnson Geel site seeks a Contamination Control Program Owner to lead and maintain the site-wide strategy for preventing microbiological contamination. You will work with multiple departments and Site Leadership to ensure a robust, scientifically sound CCP that supports patient safety and product quality.

The role involves leading risk assessments, defining control points, evaluating residual risks, and driving continuous improvement while collaborating with global CCP networks and

Qualifications

• Experience in GMP-environments.
• Demonstrated knowledge of microbiological contamination control, cleanroom management, Annex 1 and Quality Risk Management.

Responsibilities

• Ownership of the Geel Contamination Control Program (CCP).
• Lead contamination risk assessments and CCP reviews with defined control points.

Skills

GMP experience

Microbiological contamination control

Project management

Stakeholder management

Quality Risk Management

Annex 1 Knowledge

Education

Bachelor's or higher in Science/Engineering

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Supply Chain Engineering

Job Sub Function:

Quality Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Geel, Antwerp, Belgium

Job Description:

Geel Site | Johnson & Johnson Innovative Medicine

Do you want to play a key role in protecting product quality and patient safety?

We are looking for a Contamination Control Program Owner (CCP Owner) who will take the lead in further developing and maintaining our site-wide strategy for the prevention of microbiological contamination.

As CCP Owner, you are the central point of contact for the contamination control strategy at the Geel site. You work with the various departments and Site Leadership to ensure a robust, scientifically sound and future-oriented contamination control program.

Your responsibilities

Ownership of the Geel CCP.

Leading contamination risk assessments and CCP reviews: Defining contamination control measures and critical control points.

Evaluating residual risks and opportunities for improvement.

Ensuring consistent application of Quality Risk Management within the CCP.

Evaluating trends and state-of-control indicators.

Providing impact analysis for the introduction of new products and for facility, utility and process changes.

Driving continuous improvement initiatives based on innovations and best practices.

Representing the site within global CCP-related networks.

Supporting inspections, audits and management reviews.

Ensuring periodic reviews and lifecycle management of the CCP.

Participating in Change Control Boards and relevant governance forums.

Your profile

Strong scientific and technical background.

Experience in GMP-environments.

Demonstrated experience and knowledge of microbiological contamination control, cleanroom management, Annex 1 and Quality Risk Management.

Strong stakeholder management and communication skills.

Strong project management skills.

Ability to think strategically and deliver operational impact.

Required Skills:

Preferred Skills:

AI Judgement Integration, Coaching, Consistency, Controls Compliance, Critical Thinking, Data Savvy, Engineering, Financial Competence, Good Automated Manufacturing Practice (GAMP), ISO 9001, Lean Supply Chain Management, Leverages Information, Process Improvements, Quality Control Testing, Quality Standards, Quality Systems Documentation, Quality Validation, Science, Technology, Engineering, and Math (STEM) Application, Technologically Savvy

The anticipated base pay range for this position is:

€74000,00 - €117530,00

Benefits:

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.